Back to resultsStonewall Treatment Evaluation Project (STEP)
Primary Purpose
Substance Abuse, HIV Infections
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Stonewall Project
Sponsored by
About this trial
This is an interventional treatment trial for Substance Abuse focused on measuring methamphetamine, men who have sex with men, HIV/AIDS
Eligibility Criteria
Inclusion Criteria:
- Participants in the outcome evaluation must have initiated services at the Stonewall Project within the past 60 days.
Exclusion Criteria:
- Inability to provide informed consent as judged by the Co-PI's and study team.
Sites / Locations
- San Francisco AIDS Foundation
- University of California, San Francisco
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Stonewall Project Participants
Arm Description
Outcomes
Primary Outcome Measures
stimulant use (measured via self-report and urine toxicology screening)
Participants will complete a self-report measure that assesses substance use during the past month. We will examine the total number of days that stimulants (cocaine, crack, or methamphetamine) were used during the past month. We will also conduct urine toxicology screening to determine whether participants test positive for cocaine or methamphetamine metabolites at each study visit. This is an objective measure of recent stimulant use (i.e., during the past 72 hours).
Secondary Outcome Measures
sexual risk taking
Sexual risk taking will be assessed using a measure that allows our team to examine risk as a function of HIV status, partner type (i.e., insertive or receptive), and whether the participant was under the influence of methamphetamine. Sex risk for HIV-negative men will be defined as any unprotected anal intercourse, irrespective of the HIV serostatus of sex partners. Sex risk for HIV-positive men will be defined as unprotected anal intercourse with HIV-negative or unknown serostatus partners.
Full Information
NCT ID
NCT01129401
First Posted
May 6, 2010
Last Updated
October 23, 2014
Sponsor
University of California, San Francisco
Collaborators
California HIV/AIDS Research Program
1. Study Identification
Unique Protocol Identification Number
NCT01129401
Brief Title
Stonewall Treatment Evaluation Project
Acronym
STEP
Official Title
Evaluation of a Harm Reduction Treatment for Methamphetamine-Using Men Who Have Sex With Men (MSM)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
California HIV/AIDS Research Program
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This treatment outcome evaluation of the Stonewall Project will recruit 150 participants to complete a face-to-face assessment visit at baseline, 3-month follow-up, and 6-month follow-up to examine treatment outcome with respect to HIV risk and substance use.
Detailed Description
Stonewall Project clients who have initiated treatment within the past 60 days will be eligible for the outcome evaluation. 20% of clients are likely to be on parole or probation; these clients will be eligible to participate in the study.
Outcome measures that will be examined as part of the treatment outcome evaluation include: 1) self-reported substance use; 2) urine toxicology screening; and 3) sex risk taking.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Abuse, HIV Infections
Keywords
methamphetamine, men who have sex with men, HIV/AIDS
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Stonewall Project Participants
Arm Type
Other
Intervention Type
Behavioral
Intervention Name(s)
Stonewall Project
Intervention Description
The Stonewall Project is an outpatient substance abuse treatment program for methamphetamine-using MSM that includes individual counseling, group counseling, and visits with a psychiatrists where indicated.
Primary Outcome Measure Information:
Title
stimulant use (measured via self-report and urine toxicology screening)
Description
Participants will complete a self-report measure that assesses substance use during the past month. We will examine the total number of days that stimulants (cocaine, crack, or methamphetamine) were used during the past month. We will also conduct urine toxicology screening to determine whether participants test positive for cocaine or methamphetamine metabolites at each study visit. This is an objective measure of recent stimulant use (i.e., during the past 72 hours).
Time Frame
3 and 6 month follow-ups
Secondary Outcome Measure Information:
Title
sexual risk taking
Description
Sexual risk taking will be assessed using a measure that allows our team to examine risk as a function of HIV status, partner type (i.e., insertive or receptive), and whether the participant was under the influence of methamphetamine. Sex risk for HIV-negative men will be defined as any unprotected anal intercourse, irrespective of the HIV serostatus of sex partners. Sex risk for HIV-positive men will be defined as unprotected anal intercourse with HIV-negative or unknown serostatus partners.
Time Frame
3 and 6 month follow-ups
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- Participants in the outcome evaluation must have initiated services at the Stonewall Project within the past 60 days.
Exclusion Criteria:
- Inability to provide informed consent as judged by the Co-PI's and study team.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam W Carrico, Ph.D.
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
William J Woods, Ph.D.
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael D. Siever, Ph.D.
Organizational Affiliation
San Francisco AIDS Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Francisco AIDS Foundation
City
San Francisco
State/Province
California
ZIP/Postal Code
94103
Country
United States
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94105
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.stonewallsf.org/
Description
Related Info
Learn more about this trial
Stonewall Treatment Evaluation Project
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